1. Field of the Invention
This invention pertains generally to diabetes care and management, and more specifically to a multi-function wristwatch which aids in the management of diabetes.
2. Description of the Related Art
Diabetes describes disease afflicting an estimated sixteen million Americans, and 135 million people world-wide. The disease is characterized by high levels of blood glucose resulting from an inability to produce a sufficient amount or properly use insulin, a hormone necessary for the body to properly convert sugar, starches and other food into a cellular energy source. There are four types of diabetes that are recognized, including: type 1 Insulin Dependent Diabetes Mellitus (IDDM or juvenile diabetes); type 2 Non-Insulin Dependent Diabetes Mellitus (NIDDM or adult onset diabetes); gestational diabetes; and diabetes caused by surgery, drugs, malnutrition, infections, and illnesses.
Complications from diabetes are severe, disabling, and may potentially lead to death. Among the complications are heart disease and stroke, which is the leading cause of diabetes-related deaths, high blood pressure, blindness, kidney disease, nervous system damage, amputations, dental disease, pregnancy complications, diabetic ketoacidosis, and hypersmolar nonketotoic coma. Each of these complications are greatly and adversely influenced by the presence of diabetes. For example, heart disease death rates and risk of stroke are two to four times higher in adults with diabetes than in adults without diabetes. Diabetes is the leading cause of new cases of blindness in adults twenty to seventy-four years in age, and is also the leading cause of end-stage renal disease.
While there is no known cure for diabetes, treatment addresses management of blood glucose levels through dietary control, exercise and medication. The treatment requires a strict regimen that may include of a combination of insulin injections and/or oral medication, multiple daily blood glucose tests, a carefully calculated diet, and planned physical activity. In spite of awareness of the need to follow the regimen, and the seriousness of the consequences of failure to follow it, many diabetics find management to be very difficult at best. In one study of more than 600 diabetes patients, two-thirds agreed that following doctor's recommendations for diabetes care is not easy, and 41 percent indicated that they did not feel successful at managing their diabetes. The largest problem areas identified were related to exercise and diet, which are critical aspects of diabetes care.
According to clinical studies sponsored by the National Institutes of Health, better management would enable people with diabetes to reduce or significantly delay the onset of many of the serious diabetes-related health complications. Nevertheless, and as aforementioned, the management of diabetes has been particularly difficult in those afflicted with the disease. As a result, the annual financial toll has been estimated by the American Diabetes Association at more than $92 billion dollars in the United States in medical expenses, disability and lost wages each year.
Efforts at improving self-management are being made, with significant direct expenditures coming from the United States Congress. In the 1997 Balanced Budget Act, coverage for self-management services provided outside of hospital settings were estimated at a five year amount of $2.1 billion. The goal was to help Medicare beneficiaries better control their blood sugar levels and reduce expensive complication of diabetes. An additional $150 million over five years was targeted to research on type 1 diabetes, with the same amount directed to Indian Health Services for more intensive diabetes prevention and treatment services. Discretionary Health and Human Services spending was set to $345 million for fiscal year 1997 alone. Nevertheless, and in spite of these enormous expenditures, there still remains a serious and unfilled need for a way to provide effective self-management.
There have been a number of devices, systems and methodologies introduced in the prior art. These references and their teachings, as they may pertain to the design and implementation of the present invention, are incorporated herewith. While specific features are discussed hereinbelow, it will be evident that these documents would in various sections not specifically referenced provide a base upon which those of ordinary skill in the art, given the present disclosure, could be directed and guided to implement the present invention, without further undue effort or research. Each of these relevant sections, referenced or otherwise, are considered to be incorporated herein for the purposes of enabling those skilled in the art to make and use the present invention.
In regard to diabetes management systems, U.S. Pat. No. 4,731,726 to Allen, III discloses a checkbook-size portable monitor and management device that includes components for measuring, storing and providing blood glucose values. In addition to the monitoring of blood glucose, a dietary assessment module is provided. Food intake, caloric intake and food exchange are listed as the type of assessment. In U.S. Pat. No. 5,019,974 to Beckers, a hand-held diabetes management device includes features of recording information relating to insulin types and doses, diet, exercise, and other data. Insulin therapy is described, including an audible alarm at a programmed time. Diet therapy is described using one of an exchange system, above/normal/below, or followed/skipped system. A low battery symbol is also provided. There is a brief description of the software, and a reference to the program stored in a 32 KB memory chip. U.S. Pat. No. 5,107,469 to Dodson describes portable reflectance photometer systems having an LCD display and also being able to sound alarm signals to alert diabetics of the need for monitoring glucose levels, receiving an insulin injection, or ingesting requisite food supplements. The device of U.S. Pat. No. 5,307,263 to Brown is primarily directed to children afflicted with diabetes. A Nintendo of America "Game Boy" serves as the hand-held computer, and cartridges are provided to control the device and performed desired functions. Other devices are described as alternatives to the Nintendo Game Boy, including palm top computers and personal appointment calendars. Therein, they state that they provide a self-care blood glucose monitoring system which adapts a hand held microprocessor unit for supplying control signals and signals representative of food intake or other useful information and for displaying information or instruction from a health care professional.
These prior art diabetes management systems fail to provide a convenient way for the entire range of diabetic population to readily manage their care. In particular, these devices are not designed to be body attached nor do they have the simple functioning required by juvenile diabetics and also functioning preferred by older diabetics. Pocket calculator type devices tend to be dropped and broken, misplaced, and lost. In harsher climates, the devices may be destroyed by only a few hours exposure to the elements. A child who wishes to partake in the needed physical activities must set the important management device down and risk forgetting to pick it up again.
In the prior art, there are also watches provided with various physiological monitoring. While these are not generally a part of the present-day diabetes management approach, the teachings incorporated herein by reference to these devices are important to the understandings of the operation and functioning of the present invention, and an appreciation for the novelty therein. In U.S. Pat. No. 4,837,719 to McIntosh et al, a temperature monitor, blood pressure monitor, and pulse rate monitor are combined together with a timer/alarm. In U.S. Pat. No. 5,012,229 to Lennon et al, a wrist watch includes basic heart rate monitoring in conjunction with time keeping and Med-Alert type data. In U.S. Pat. No. 5,602,802 to Leigh-Spencer et al, a portable medication reminder is disclosed as being provided with a hole to facilitate attachment of the module to a separate article regularly carried by the patient, for example, a key ring. A low-battery indication is also provided. In U.S. Pat. No. 5,628,324 to Sarbach a bio-monitoring device may be placed on the handlebar of a bicycle, in the manner most suited to the type of use, and may be combined with time or stopwatch functions. Display means comprise a conventional hour, minute and second display, and a special display of the parameters measured by the processing device. The display may also comprise flags and symbols corresponding to parameters to be displayed or to certain special circumstances, for example the end of the batteries' life. The watch also comprises push buttons enabling different functions to be called. In U.S. Pat. No. 5,691,932 to Reiner et al, a care-giver data collection and reminder system includes schedules to remind the care giver of medication times, feedings, etc. Icons are provided to assist in international use and to simplify the operation of the device. Alarms can be initiated by the micro-controller and can either be a display device or auditory. The apparatus includes a carrying case that allow the operator to attach the device on a changing table, to their belt, refrigerator, or to carry it around the neck or wrist. In U.S. Pat. No. 5,719,780 to Holmes and Moe, a medication reminder takes a wrist watch configuration, and also includes a low battery indicator. The device may be placed in a pill box, or may be worn around the neck or provided on a key chain.
In the area of diet management, U.S. Pat. No. 5,542,420 to Goldman et al discloses a diet management system implemented in a notebook PC or similar device. Included with the diet management is the requirement for pharmaceuticals and carbohydrates. U.S. Pat. No. 4,911,256 by Attikiouzel and U.S. Pat. No. 5,233,520 by Kretsch et al each disclose "smart scales" that are programmed to help with dietary management, and U.S. Pat. No. 5,691,927 to Gump discloses a hand-held food pyramid diet calculator.
Additional patents that are incorporated herein for their more general teachings of related programming and hardware and software implementation are U.S. Pat. No. 4,858,207 by Buchner, U.S. Pat. No. 5,233,571 by Wirtschafter, U.S. Pat. No. 5,371,687 by Holmes, II et al, U.S. Pat. No. 5,678,571 by Brown, U.S. Pat. No. 5,701,894 to Cherry et al, and U.S. Pat. No. Des. 390,666 to Lagerloff.